Fracture risk and the use of a diuretic (indapamide sr) ± perindopril:: a substudy of the Hypertension in the Very Elderly Trial (HYVET)

被引:13
作者
Bulpitt, Christopher J. [1 ]
Peters, Ruth
Staessen, Jan A.
Thijs, Lutgarde
De Vernejoul, Marie-Christine
Fletcher, Astrid E.
Beckett, Nigel S.
机构
[1] Univ London Imperial Coll Sci Technol & Med, Fac Med, London SW7 2AZ, England
[2] Katholieke Univ Leuven, Louvain, Belgium
[3] Hosp Lariboisiere, Paris, France
[4] London Sch Hyg & Trop Med, London WC1, England
关键词
D O I
10.1186/1745-6215-7-33
中图分类号
R-3 [医学研究方法]; R3 [基础医学];
学科分类号
1001 ;
摘要
Background: The Hypertension in the Very Elderly Trial ( HYVET) is a placebo controlled double blind trial of treating hypertension with indapamide Slow Release ( SR) +/- perindopril in subjects over the age of 80 years. The primary endpoints are stroke ( fatal and non fatal). In view of the fact that thiazide diuretics and indapamide reduce urinary calcium and may increase bone mineral density, a fracture sub study was designed to investigate whether or not the trial anti-hypertensive treatment will reduce the fracture rate in very elderly hypertensive subjects. Methods: In the trial considerable care is taken to ascertain any fractures and to identify risk factors for fracture, such as falls, co-morbidity, drug treatment, smoking and drinking habits, levels of activity, biochemical abnormalities, cardiac irregularities, impaired cognitive function and symptoms of orthostatic hypotension. Potential results: The trial is expected to provide 10,500 patient years of follow-up. Given a fracture rate of 40/1000 patient years and a 20% difference in fracture rate, the power of the sub study is 58% to detect this difference at the 5% level of significance. The corresponding power for a reduction of 25% is 78%. Conclusion: The trial is well under way, expected to complete in 2009, and on target to detect, if present, the above differences in fracture rate.
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页数:6
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